FDA 510(k)

gammaCore Sapphire

K 號：K182369 · 2018-11-27

決定日期2018-11-27

產品代碼PKR

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

gammaCore Sapphire is the device name listed in this FDA 510(k) record. The listed applicant is Electrocore, Inc.. It received FDA 510(k) clearance on 2018-11-27 under 510(k) number K182369. The device is classified under product code PKR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the gammaCore Sapphire?

gammaCore Sapphire is a medical device that received FDA 510(k) clearance on 2018-11-27. The listed applicant is Electrocore, Inc.. The 510(k) number is K182369.

When did gammaCore Sapphire receive FDA 510(k) clearance?

gammaCore Sapphire received FDA 510(k) clearance on 2018-11-27, under 510(k) number K182369.

Who is the listed applicant for gammaCore Sapphire?

The FDA 510(k) record lists Electrocore, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for gammaCore Sapphire?

The FDA product code for gammaCore Sapphire is PKR.

其他以 Electrocore, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K211856gammaCore Sapphire K203546gammaCore Sapphire K191830gammaCore Sapphire

相關器械（代碼：PKR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K211856gammaCore SapphireElectrocore, Inc.K203546gammaCore SapphireElectrocore, Inc.K191830gammaCore SapphireElectrocore, Inc.K180538gammaCore SapphireElectrocore, LLC K173442gammaCore-SElectrocore, LLC K172270gammaCore-2Eletrocore, LLC

官方來源

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